Drug application

PROMETHACON (PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 084902 · POLYMEDICA

Key facts

Drug name PROMETHACON
Active ingredients PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 084902
Company POLYMEDICA
Dosage forms SUPPOSITORY, RECTAL
Strength 50MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Oct 5, 1981

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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